Recent Regulatory Scenario of Nitrosamines Impurities in Regulated Market US, Europe and Canada

  • Richa Trivedi School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan (Deemed to be University), Bhubaneswar 751003, Odisha, India
  • Ankit Trivedi
  • Vinit Movaliya
  • Khushboo Vaghela
  • Niranjan Kanaki
  • Shrikalp Deshpande
  • Maitreyi Zaveri


Unexpected finding of cancer causing, DNA damaging impurities called nitrosamine impurities which are mostly likely to present in structures containing nitroso group as per EMA and also according to ICH M7 is a member of “cohort of concern “class of high potency mutagenic carcinogens. In year 2018 it was first detected in sartans by USFDA after that it found in found in antacid like nizatidine, ranitidine and in anti-diabetic drugs like metformin, pioglitazone. There are nearly more fifteen types of impurities detected in products like NDMA, NDEA, EIPNA, NMBA, NDBA, and MeNP. Thousands of batches were recalled in countries like USA, Europe and all around world. Regulatory bodies of like USFDA, EMA and Health Canada has published  stringent guidelines and documents to control carcinogenic impurities and given timelines for submission of risk assessment and confirmatory test and submission of other documents if change in process to mitigate its level and suggested  changes in manufacturing process like change in ROS ,Control strategy etc. Along with the Q&A, roots cause for presence of impurities .Immediate submission of the amount of Nitrosamine impurities when detected in product and if negligible amount is present no need to submit report.

Keywords: Nitrosamines Impurities, NDMA, NDEA, EIPNA, NMBA, NDBA, Root Cause, USFDA, EMA, Health Canada


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How to Cite
Trivedi, R., A. Trivedi, V. Movaliya, K. Vaghela, N. Kanaki, S. Deshpande, and M. Zaveri. “Recent Regulatory Scenario of Nitrosamines Impurities in Regulated Market US, Europe and Canada”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 30-36, doi:10.22270/ijdra.v11i2.581.

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